• Advanced Biomaterial Systems (ABS; Chatham, New Jersey) received 510(k) clearance from the FDA to market Symphony VR Radiopaque Bone Cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. The company said the clearance allows it to market its Plexis mixing and delivery system together with the Symphony VR bone cement as a complete and controlled solution to spine physicians for stabilizing spinal compression fractures.

• Advanced Magnetics (Cambridge, Massachusetts) and Cytogen (Princeton, New Jersey) said that clinical data published in the December issue of Public Library of Science Medicine shows for the first time the feasibility of computer-assisted lymph node staging using Combidex, Advanced Magnetics' investigational molecular imaging agent. Combidex (ferumoxtran-10) consists of iron oxide nanoparticles for use in conjunction with MRI to aid in the differentiation of cancerous from non-cancerous lymph nodes. The research was conducted by Mukesh Harisinghani, MD, assistant professor in radiology at Massachusetts General Hospital (MGH) and Ralph Weissleder, MD, PhD, director of the Center for Molecular Imaging Research at MGH and professor of radiology at Harvard Medical School (both Boston). In the 70-patient study, the magnetic tissue parameters of cancer metastases and normal unmatched lymph nodes were measured in pre- and post-Combidex enhanced images using a learning dataset consisting of 97 histologically proven nodes from 36 patients. Unique magnetic characteristics were found that accurately distinguished metastatic from normal nodes with an overall sensitivity of 98% and specificity of 92%. Cytogen has exclusive U.S. marketing rights to Combidex.

• Bayer HealthCare AG (Leverkusen, Germany) and Nektar Therapeutics (formerly Inhale Therapeutic Systems; San Carlos, California) reported a new collaboration to develop an inhaleable powder formulation of a novel form of Ciprofloxacin (Cipro) to treat chronic lung infections caused by Pseudomonas aeruginosa in cystic fibrosis patients. The announcement was made at this week's Drug Delivery Partnerships Conference in San Diego. Under the terms of the collaboration, Nektar will be responsible for formulation of the dry powder and development of the inhalation system, as well as clinical and commercial manufacturing of the drug formulation and device combination. Bayer will be responsible for the clinical development and worldwide commercialization of the system. Nektar will receive funding for pre-clinical development, milestone payments, and royalty payments when the product is commercialized. P. aeruginosa is the most common pathogen in patients with cystic fibrosis with the vast majority becoming chronically colonized with this organism, resulting in repeated cycles of lung inflammation and consequent deterioration in lung function. Cipro is a potent anti-pseudomonal quinolone antibiotic that is available in oral and intravenous formulations.

• Datatrak International (Cleveland), an application service provider in the electronic data capture (EDC) industry, has released Version 4.0 of the Datatrak EDC Product Suite. The company said Version 4.0 represents significant advancements in software engineering and architecture, including an integrated study design architecture that will allow for an almost effortless “push button“ amendment or “mid-study change“ process. Datatrak noted that study amendments are frequently perceived to be a major difficulty of all EDC systems, but that Version 4.0 has solved this problem by automatically linking any changes to the electronic case report form (eCRF) directly to an appropriate reconfiguration of the database in a manner that is transparent to the user. Version 4.0 is compliant with the Operational Data Model (ODM), Version 1.2 from Clinical Data Interchange Standards Consortium for transfers of data to and from the company's EDC system. Because of its open architecture, Version 4.0 also will be capable of converting clinical trials begun with another EDC product over to Datatrak EDC.

No Comments